The following data is part of a premarket notification filed by Diagnostic Systems with the FDA for Visual Blood Glucose Test System.
| Device ID | K884993 |
| 510k Number | K884993 |
| Device Name: | VISUAL BLOOD GLUCOSE TEST SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DIAGNOSTIC SYSTEMS 454 S. ANDERSON RD. BTC 502 Rock Hill, SC 29730 |
| Contact | Constance Ducar |
| Correspondent | Constance Ducar DIAGNOSTIC SYSTEMS 454 S. ANDERSON RD. BTC 502 Rock Hill, SC 29730 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-01 |
| Decision Date | 1988-12-29 |